Cruz, Lee Introduce the RESULT Act

December 11, 2015

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202-228-7561

WASHINGTON, D.C. — On Thursday, U.S. Sens. Ted Cruz (R-Texas) and Mike Lee (R-Utah) introduced the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act,” which would amend the Food, Drug and Cosmetic Act to allow for reciprocal approval of drugs. Specifically, the RESULT Act would require the Food and Drug Administration (FDA) to quickly review drug, device, and biologic applications from sponsors who have products approved and sold in developed and trustworthy countries. This will deliver lifesaving treatments and cures to American doctors and patients from countries we trust. Americans suffering from chronic and life-threatening conditions will be able to access drugs and devices, which are currently saving lives in other developed countries, but have not been approved in the U.S. because of FDA red tape.

Upon introducing this bill, Sen. Cruz said, “We need to tear down the barriers blocking a new era of medical innovation, and the primary inhibitor is the government itself. It’s past time to unleash a supply-side medical revolution, so that instead of simply caring for people with debilitating diseases, we cure them. For this reason, I have introduced this legislation to reform the FDA and champion innovation. Our legislation will unleash life-saving drugs and devices in the United States, help mitigate critical drug shortages in the U.S., and put downward pressure on the prices of medical devices and drugs as well.”

Sen. Lee said, “Much broader reform of the FDA is needed, but this common sense legislation would at least help some of the most vulnerable among us get the life saving treatments they need that are already helping people in other countries.”

Highlights of the RESULT Act include:

•Amending the Food, Drug and Cosmetic Act to allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in certain trusted, developed countries including EU member countries, Israel, Australia, Canada and Japan.

•Encouraging the FDA to expeditiously review life-saving drug and device applications, this legislation would provide the FDA with a 30-day window to approve or deny a sponsor’s application. Qualifying medical products are already approved and sold in developed nations with a satisfactory history of clinical trials and data.

•The HHS Secretary is instructed to approve a drug, device or biologic if the FDA confirms the product is:

◦Lawfully approved for sale in one of the listed countries;

◦Not a banned device by current FDA standards;

◦There is a public health or unmet medical need for the product.

•If a promising application for a life-saving drug is declined Congress is granted the authority to disapprove of a denied application and override an FDA decision with a majority vote via a join resolution.

•Quick and safe reciprocal approval would help relieve some of the drug shortage problems by allowing numerous safe and qualified alternatives to enter the U.S. market. Health care providers and their patients who need critical and commonly used generic medications including cancer drugs, antipsychotic drugs for mental health emergencies, anesthetics and much more could will benefit from increased competition and a greater supply of drugs and devices.